Optimizing Stroke Family Caregiver Support Across the Care Continuum by Improving the Timing of Intervention Delivery
研究概览
地位
条件
详细说明
The objective of this multi-province randomized controlled trial will be to determine if the TIR Stroke Family Support Program delivered across the care continuum contributes to positive caregiver outcomes. Since this program targets family caregiver support, the primary outcomes of the intervention will be caregivers' perception of being supported in their care-giving role and improvements in caregiver mental health outcomes (e.g., less depression and more psychological well-being). To determine the impact of the intervention on caregiver outcomes, we will compare two modes of intervention delivery with standard care: 1) repeated contact in person and by telephone with a stroke support person and 2) a self-directed program by the caregiver.
We will perform a multi-site, mixed methods RCT. Caregivers of patients who are receiving acute care for their first stroke will be recruited within the first week of hospital admission. Members of the stroke team from the participating hospitals' stroke units will identify potential participants and ask their permission to be approached by each site's research assistant. The research assistant will fully explain the study, answer questions, obtain consent, administer the baseline questionnaires, and then contact the project coordinator who will then randomize participants to one of three groups: A) TIR Stroke Family Support Program delivered by a stroke support person, B) caregiver self-directed TIR Stroke Family Support Program, and C) usual care that includes provision of the Heart and Stroke educational resource "Let's Talk about Stroke". The research assistants will give caregivers a copy of "Let's Talk about Stroke" (if they have not yet received a copy) and introduce them to the stroke support person who will deliver the full intervention and instruct the family in the use of the self-directed arm of the intervention. A second part-time research assistant blinded to group assignment will complete routine follow-up assessments with participants at 3, 6, and 12 months post-stroke. A subset of 36 participants (6 from each site) will also participate in a qualitative interview after completion of their 12-month follow-up assessment.
The goals of this multi-site randomized controlled trial are to:
- Assess whether the intervention improves caregivers outcomes (via quantitative analysis)
- Assess how the intervention improves caregiver outcomes (via qualitative analysis)
- Assess how the intervention is delivered (via stroke support person journals)
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G 1V7
- University of Toronto -- Dpt. of Occupational Science and Occupational Therapy
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants must speak and read English and be the primary family caregiver of a person who is receiving care for their first hospitalization for an ischemic or hemorrhagic stroke and whose anticipated ultimate destination after discharge is a private residence or apartment building.
- Stroke survivors must exhibit at least minimal disability (i.e., are referred to at least one rehabilitation health care professional during acute care). They may be admitted to short or long-duration inpatient (maximum duration of 6 months) or outpatient rehabilitation or return directly home.
Exclusion Criteria:
- Caregivers of terminally ill stroke survivors or of survivors discharged to complex continuing care, long-term care or assisted retirement residences.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Self-Directed Program
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Participants in this arm of the trial will have family caregivers self-direct their use of the Timing it Right Stroke Family Support guide.
The research assistant will instruct the caregivers how to self-manage their support needs by providing instruction on how to use the guide, which has an additional section regarding self-management.
Caregivers will also be instructed that the guide is organized according to the phases of a stroke survivors' recovery.
They will be instructed to review the information in each chapter as it becomes relevant to their current situation
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有源比较器：Stroke Support Person
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Intervention delivered by a stroke support person (SSP) in-person during acute care & by telephone during inpatient rehabilitation and community discharge.
SSP provides support, information & guidance and gives caregivers Stroke Family Support guide as a resource.
SSP will have 1 contact with the caregiver during acute care and a 2nd contact during the last week of inpatient acute or rehabilitation care.
The 1st contact while the caregiver is at home will occur 2-3 weeks after the stroke survivor has been discharged from inpatient care and then every four weeks until the caregiver passes the marker question.
SSP will then encourage caregiver to contact them if they have any specific questions.
The SSP will make one final contact about 8 weeks later
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无干预：Standard Care
Participants in this arm receive Standard Care which consists of being given a copy of the Heart& Stroke Foundation's stroke resource titled "Let's Talk About Stroke"
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale.
大体时间：Baseline, 3, 6 and 12-months post-stroke
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Baseline, 3, 6 and 12-months post-stroke
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次要结果测量
结果测量 |
大体时间 |
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Positive/negative mental health outcomes will be assessed by the Positive Affect Scale and Centre for Epidemiological Studies Depression Scale, respectively. Caregivers' participation in valued activities will be assessed by the Caregiving Impact Scale
大体时间：Baseline, 3, 6 and 12-months post-stroke
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Baseline, 3, 6 and 12-months post-stroke
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合作者和调查者
合作者
调查人员
- 首席研究员：Jill Cameron, PhD、University of Toronto
出版物和有用的链接
一般刊物
- Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Cameron JI, Gignac MA. "Timing It Right": a conceptual framework for addressing the support needs of family caregivers to stroke survivors from the hospital to the home. Patient Educ Couns. 2008 Mar;70(3):305-14. doi: 10.1016/j.pec.2007.10.020. Epub 2007 Dec 21.
- Cameron JI, Naglie G, Gignac MA, Bayley M, Warner G, Green T, Czerwonka A, Huijbregts M, Silver FL, Phillips SJ, Cheung AM. Randomized clinical trial of the Timing it Right Stroke Family Support Program: research protocol. BMC Health Serv Res. 2014 Jan 17;14:18. doi: 10.1186/1472-6963-14-18.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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